Decision

Dupilumab in the treatment of children aged 6 to 11 years of age with severe atopic dermatitis (allergic eczema)

EAMS scientific opinion issued to Sanofi for dupilumab in the treatment of children aged 6 to 11 years with severe atopic dermatitis (allergic eczema) that is not controlled by medicines applied as creams or ointments to the skin.

Documents

Dupilumab: Public Assessment Report (PAR)

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Dupilumab: Treatment protocol: Information for healthcare professionals

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Dupilumab: Treatment protocol: Information for patients

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Dupilumab: Treatment protocol: Information on the Pharmacovigilance System

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Dupilumab: Information for NHS Medical Director

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Details

For the full EAMS indication please see section 4.1 of the Treatment protocol: Information for healthcare professionals

The scientific opinion includes:

  • a public assessment report (PAR)
  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system
  • Information for NHS Medical Directors

Information and details regarding patient access

For new patients wishing to access EAMS medicines in England, trusts must register patients on the NHS England web-based registration system. Queries to NHS England regarding the scheme can be submitted to england.eams@nhs.net.

For information about access in Northern Ireland, contact Chief Pharmaceutical Officer and Joe Magee, Secondary Care Directorate at Joe.Magee@dhsspsni.gov.uk.

For information about access in Scotland contact the Scottish Government Directorate General Health & Social Care at medicines.policy@gov.scot.

For information about access in Wales, contact the Welsh Government Health and Social Services Group by emailing Andrew Evans, Chief Pharmaceutical Officer or Lynne Schofield, Head of Pharmacy and Prescribing policy at Pharmacyand.PrescribingBranch@gov.wales.

Published 17 August 2020